Comprehensive Geriatric Assessment (Tests) for Bladder Cancer Participants Undergoing Radical Cystectomy

NCT ID: NCT06427824

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-09

Study Completion Date

2026-10-01

Brief Summary

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This study focuses on providing an educational program for people/participants with bladder cancer who plan to have a cystectomy (surgery) as part of their standard care. Participants in this study will watch videos designed to teach them strategies to help lower their risk of experiencing negative side effects (such as mobility problems, issues with taking medication, and poor quality of life) before and after they have surgery. They will also be asked to fill out questionnaires.

Detailed Description

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This study focuses on providing an educational program for participants/people with bladder cancer who plan to have a cystectomy (surgery) as part of their standard care. Participants in this study will watch videos designed to teach them strategies to help lower their risk of experiencing negative side effects (such as mobility problems, issues with taking medication, and poor quality of life) before and after they have surgery. The goal of this study is to educate people with bladder cancer and ask them to also fill out questionnaires about the education program and if they used any of the strategies that learn during the study.

Participants in this study will be divided into two different study groups (one group that watches educational videos before surgery and one group that watches educational videos before surgery and also receives geriatric services and follow up visits after surgery). Each participant will be randomized (randomly assigned) to one of two study groups. That means that there is a 50/50 chance (like flipping a coin) that each participant will end up in either group.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Participants Who Watch Educational Videos Before Surgery

Participants in this group will attend an educational session in a conference room that includes 4 learning modules on strategies to reduce mobility loss, improve medication management, prevent delirium, and to document what matters most before and after surgery (cystectomy). These learning modules will be in video format. Participants will watch videos to learn about pre/post surgical strategies and they will receive informational handouts after watching the videos. The study team will also ask participants to fill out questionnaires/surveys before and after surgery.

Group Type EXPERIMENTAL

Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery)

Intervention Type OTHER

An educational program designed by geriatricians, surgeons, anesthesiologists and palliative care physicians to help people with bladder cancer who plan to receive a cystectomy learn strategies to improve their mobility, medication management, mental clarity/delirium and how they document important side effects or health issues after surgery.

Questionnaires

Intervention Type OTHER

These questionnaires will ask about the participants' mobility, frailty, quality of life and additional health/risk factors before and after surgery.

Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services

Participants in this group will also attend an educational session in a conference room that includes 4 learning modules on strategies to reduce mobility loss, improve medication management, prevent delirium, and to document what matters most before and after surgery (cystectomy). These learning modules will be in video format. Participants will watch videos to learn about pre/post surgical strategies and they will receive informational handouts after watching the videos. The study team will also ask participants to fill out questionnaires/surveys before surgery.

In addition to attending the educational program (via video) and receiving informational handouts, participants in this group will also meet with the study doctor and/or members of the study team after surgery to help plan their hospital discharge and reinforce/use the strategies they learned in the educational session after surgery.

Group Type EXPERIMENTAL

Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery)

Intervention Type OTHER

An educational program designed by geriatricians, surgeons, anesthesiologists and palliative care physicians to help people with bladder cancer who plan to receive a cystectomy learn strategies to improve their mobility, medication management, mental clarity/delirium and how they document important side effects or health issues after surgery.

Geriatric Service/ Discharge Planning

Intervention Type OTHER

A geriatric team will meet with participants after surgery to help them reinforce the strategies they learned in the education video sessions. As part of a geriatric service, this team will also help participants plan/coordinate their discharge from the hospital after surgery.

Questionnaires

Intervention Type OTHER

These questionnaires will ask about the participants' mobility, frailty, quality of life and additional health/risk factors before and after surgery.

Interventions

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Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery)

An educational program designed by geriatricians, surgeons, anesthesiologists and palliative care physicians to help people with bladder cancer who plan to receive a cystectomy learn strategies to improve their mobility, medication management, mental clarity/delirium and how they document important side effects or health issues after surgery.

Intervention Type OTHER

Geriatric Service/ Discharge Planning

A geriatric team will meet with participants after surgery to help them reinforce the strategies they learned in the education video sessions. As part of a geriatric service, this team will also help participants plan/coordinate their discharge from the hospital after surgery.

Intervention Type OTHER

Questionnaires

These questionnaires will ask about the participants' mobility, frailty, quality of life and additional health/risk factors before and after surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants capable of giving consent
* Participants undergoing radical cystectomy (both for curative and palliative intent) for bladder cancer diagnosed by tissue pathology with urinary diversion at the University of Chicago
* Participants undergoing neoadjuvant chemotherapy will be included
* Participants will be included regardless of gender, race or ethnicity
* Participants greater than or equal to 65 years of age

Exclusion Criteria

* Radical cystectomy for non-oncologic indications
* Palliative cystectomy for cancers other than bladder cancer (i.e. prostate, rectal, cervical)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Piyush Agarwal

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Piyush K Agarwal, MD

Role: CONTACT

773-702-3080

Facility Contacts

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Piyush Agarwal, MD

Role: primary

773-702-3080

Other Identifiers

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IRB23-0773

Identifier Type: -

Identifier Source: org_study_id

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